Benign Pigmented LesionsNCT04208100
Pilot Evaluation of the Lutronic PicoPlus System for the Treatment of Benign Pigmented Lesions of the Hands
A study testing PicoPlus in people with Benign Pigmented Lesions, run by CynosureLutronic at 1 site in United States.
Trial summary
Prospective, multi-site, non-randomized study of up to 40 treated subjects; subjects enrolled may be greater than subjects treated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Benign Pigmented Lesions
- What is being tested?
- PicoPlus
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 18 years and older.
- Subject in good health.
- Fitzpatrick Skin Type I to IV.
- Presence of benign pigmented lesions on hands.
- Understands and accepts the obligation not to undergo any other procedures in the treatment area.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
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- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
- Postmenopausal for at least 12 months prior to study;
- Without a uterus and/or both ovaries; or
- Bilateral tubal ligation at least six months prior to study enrollment.
- Absence of physical or psychological conditions unacceptable to the investigator.
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Who cannot join
- Healing disorders such as those caused by diabetes mellitus, connective tissue disease, radiation therapy, or chemotherapy.
- Subjects with a history of photosensitivity or diseases which may be stimulated by light at the wavelengths used, such as history of systemic Lupus Erythematosus, Pophyia, and Epilepsy.
- History of chronic drug or alcohol abuse.
- Inability to understand the protocol or to give informed consent.
- Subjects with a history of skin cancer or current condition of any other type of cancer or pre-malignant moles.
- Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial.
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- History of keloid formation.
- Subjects with tattoos on the backs of the hands in the treatment area.
- History of surgical or cosmetic treatments in exposure area within the past six months.
- History of tanning or use of self-tanners in the past 4 weeks.
- History of treatments that may irritate the skin in the treatment area such as depilatories, harsh chemicals, etc.) in the past 2 weeks.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, multi-site, non-randomized study of up to 40 treated subjects; subjects enrolled may be greater than subjects treated.
Read the detailed description
Subjects will be enrolled to ensure a minimum number of subjects by skin type participate in the study as follows: FST I-II, at least 5 subjects; FST III, at least 10 subjects; FST IV, at least 5 subjects. Additionally, up to 20 training subjects will be enrolled that will be excluded from efficacy analysis, but will be included in safety analysis.
Standardized baseline and follow-up images will be taken using the sites' preferred camera system. No pre-treatment medication prior to study treatment.
Phase I: Study subjects will receive up to three treatments with the PicoPlus with the 595nm on one hand and the 660nm on the other hand. Subjects will receive the same wavelength for all treatments on each specific hand; treatments will alternate by subjects between the left side getting treated with the 595nm and the right side getting treated with the 660nm depending on enrollment. Treatments will be 30+7 days apart up to three treatments until desired clearance has been achieved.
Phase II: Up to 2 balancing treatments may be done if needed based on the investigator's discretion to achieve equal clearance on each hand utilizing the wavelength of the investigator's choice. Phase II will not be considered for efficacy endpoints.
- Conditions
- Benign Pigmented Lesions
- Being tested
- PicoPlus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoPlusDevice
The PICOPLUS Laser System (K173700) is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 595nm and 660nm wavelengths of the Lutronic PicoPlus Laser system are used for the treatment of benign pigmented lesions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmentary Clearance
Percentage of pigmentary clearance by each wavelength in standard photographs from the 30-day visit post the last treatment in Phase I of the study using a score of 0-4, representing poor 0-24%, fair 25-49%, good 50-74%, excellent 75-95%, and complete 95%+ improvement was given at the day 30 follow-up visit post the last treatment as determined by three blinded physician evaluators comparing the baseline vs 30-day follow-up visit photographs.
Measured: 30 days
Secondary outcomes (2)
Clinician Global Aesthetic Scale
The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a Clinician Global Aesthetic Improvement Scale assessing overall aesthetic improvement by wavelength at the 30-day visit following the last treatment visit for Phase I of the study. Scale ranging 1-Very Much Improved and 5-Worse.
Measured: 30 days
Subject Global Aesthetic Scale
- The subject will complete a SGAIS assessing overall aesthetic improvement by wavelength at the 30-day visit following the last treatment visit for Phase I of the study. Scale Ranging 1-Very Much Improved and 5-Worse.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start13 Sep 2018
- Primary completion5 Sep 2019
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Pigmented LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208100
- Sponsor's protocol ID
- L18007
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Lutronic PicoPlus System for the Treatment of Benign Pigmented Lesions of the Hands
- ClinicalTrials.gov ID
- NCT04208100
- Acronym / sponsor ID
- L18007
- Conditions
- Benign Pigmented Lesions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-site, non-randomized study of up to 40 treated subjects; subjects enrolled may be greater than subjects treated.
Detailed description
Subjects will be enrolled to ensure a minimum number of subjects by skin type participate in the study as follows: FST I-II, at least 5 subjects; FST III, at least 10 subjects; FST IV, at least 5 subjects. Additionally, up to 20 training subjects will be enrolled that will be excluded from efficacy analysis, but will be included in safety analysis.
Standardized baseline and follow-up images will be taken using the sites' preferred camera system. No pre-treatment medication prior to study treatment.
Phase I: Study subjects will receive up to three treatments with the PicoPlus with the 595nm on one hand and the 660nm on the other hand. Subjects will receive the same wavelength for all treatments on each specific hand; treatments will alternate by subjects between the left side getting treated with the 595nm and the right side getting treated with the 660nm depending on enrollment. Treatments will be 30+7 days apart up to three treatments until desired clearance has been achieved.
Phase II: Up to 2 balancing treatments may be done if needed based on the investigator's discretion to achieve equal clearance on each hand utilizing the wavelength of the investigator's choice. Phase II will not be considered for efficacy endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female, age 18 years and older.
- Subject in good health.
- Fitzpatrick Skin Type I to IV.
- Presence of benign pigmented lesions on hands.
- Understands and accepts the obligation not to undergo any other procedures in the treatment area.
Key exclusion criteria (12 listed)
- Healing disorders such as those caused by diabetes mellitus, connective tissue disease, radiation therapy, or chemotherapy.
- Subjects with a history of photosensitivity or diseases which may be stimulated by light at the wavelengths used, such as history of systemic Lupus Erythematosus, Pophyia, and Epilepsy.
- History of chronic drug or alcohol abuse.
- Inability to understand the protocol or to give informed consent.
- Subjects with a history of skin cancer or current condition of any other type of cancer or pre-malignant moles.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PicoPlusThe PICOPLUS Laser System (K173700) is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 595nm and 660nm wavelengths of the Lutronic PicoPlus Laser system are used for the treatment of benign pigmented lesions. | Device | – |
Primary outcome
Pigmentary Clearance
Time frame: 30 days
Percentage of pigmentary clearance by each wavelength in standard photographs from the 30-day visit post the last treatment in Phase I of the study using a score of 0-4, representing poor 0-24%, fair 25-49%, good 50-74%, excellent 75-95%, and complete 95%+ improvement was given at the day 30 follow-up visit post the last treatment as determined by three blinded physician evaluators comparing the baseline vs 30-day follow-up visit photographs.
2 secondary outcomes
Clinician Global Aesthetic Scale
Time frame: 30 days
Subject Global Aesthetic Scale
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PicoPlus in people with Benign Pigmented Lesions, run by CynosureLutronic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pigmentary Clearance (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.